Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease

Официальное название

A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects With Chronic Discogenic Lumbar Back Pain Due to Degenerative Disc Disease at 6 and 12 Months

Обзор

The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.

Подробное описание

A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects with Chronic Discogenic Lumbar Back Pain due to Degenerative Disc Disease at 6 and 12 Months, male or female subjects with chronic discogenic lumbar back pain due to degenerative disc disease at one level. TG-C is to be administered by a single intradiscal injection to the damaged disc via fluoroscopic guidance. Sham will be a normal saline subcutaneous injection. Subjects will be followed for 24 months with in-clinic visits and telephone calls after study drug administration.

Вмешательства

• Биопрепарат TG-C High Dose
  High Dose - 1 mL of the combined TG-C cells
• Биопрепарат TG-C Mid Dose
  Middle Dose - A volume of 2 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
• Биопрепарат TG-C Low Dose
  Low Dose - A volume of 9 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
• Биопрепарат Sham Control
  Single subcutaneous injection of normal saline

Первичные конечные точки

• Treatment-emergent adverse events [Срок оценки: 6 and 12 months]

Вторичные конечные точки (2)

• Compare pain severity using a Visual Analogue Scale [Срок оценки: 6 and 12 months]
• Oswestry Disability Index survey [Срок оценки: 6 and 12 months]

Критерии участия

Критерии включения

• Between the ages of >= 22 and <= 70
• Provides written informed consent before undergoing any study specific procedures
• Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS
• VAS between >= 40 and <= 90
• ODI Index >30 and <= 80
• Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening.
• Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies
• Modified Pfirrmann score of 3-7 on MRI
• With or without contained disc herniations of <3 mm protrusion
• If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator
• BMI >15 and < 30 kg/m2
• Use birth control

Критерии исключения

• Co-morbid medical condition of the spine or upper extremities
• Grade 2 or higher spondylolisthesis and type III Modic changes around target disc
• Suspicion of full thickness annular tear at disc
• History of endocrine or metabolic disorder
• Rheumatoid or psoriatic arthritis
• Compressive pathology due to stenosis or herniated or sequestered discs
• Symptomatic involvement of more than one lumber disc
• Intact disc bulge/protrusion at >3 mm
• Lumbar intervertebral foraminal stenosis
• Previous surgery at the target disc level
• Epidural or facet joint steroid, platelet rich plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline.
• Pregnant
• Presence of ferromagnetic implants
• Involved in current or pending spinal litigations
• Care is provided under a Worker's Compensation claim
• Physical or mental conditions
• 3 or more of the 5 Waddell signs
• Positive screen for HIV
• Immediate family member of other participating patients
• Participated within 3 months or is concurrently enrolled in non-interventional research
• Transient or has a history of any substance use disorder
• Currently incarcerated
• Investigator site personnel or immediate family or sponsor employee
• On chronic anti-coagulation therapy or have confirmed coagulopathy
• Tested positive on RCR testing at screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06144970 · TGC-DDD-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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